AB0881 Guselkumab Provides Sustained Improvements in Health-Related Quality of Life in Patients With Active Psoriatic Arthritis Through 2 Years of DISCOVER-2
Authors: J. Curtis, I. McInnes, P. Rahman, D. D. Gladman, F. Yang, S. Peterson, A. Kollmeier, N. Shiff, C. Han, M. Shawi, W. Tillett, P. J. Mease
Journal: Annals of the Rheumatic Diseases (2022)

Background Psoriatic arthritis (PsA), a chronic inflammatory disease characterized by peripheral arthritis, axial inflammation, dactylitis, enthesitis, and skin/nail psoriasis, is associated with reduced health-related quality of life (HRQoL). Objectives To assess long-term effect of guselkumab (GUS), a human monoclonal antibody that selectively targets the interleukin (IL)-23p19 subunit, on HRQoL of bio-naïve PsA patients (pts) who participated in the Phase 3 2-year DISCOVER-2 trial. 1 Methods Pts with active PsA despite nonbiologic disease-modifying antirheumatic drugs (DMARDs) and/or nonsteroidal anti-inflammatory drugs (NSAIDs) received GUS 100 mg every 4 weeks (Q4W); GUS 100 mg at W0, W4, then Q8W; or placebo (PBO). At W24, PBO pts crossed over to GUS 100 mg Q4W. HRQoL was assessed using the pt-reported EuroQoL-5 Dimension-5 Level (EQ-5D-5L) questionnaire index and EuroQol Visual Analog Scale (EQ-VAS), widely used and complimentary tools that allow pts to provide a global assessment of their HRQoL. The EQ-5D-5L index assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; an index score is derived ranging from 0 (death) to 1 (perfect health). 2 EQ-VAS assesses pt health state on a scale of 0-100, with higher scores indicating better health. Using mixed effects models for repeated measures (MMRM), least squares (LS) mean changes from baseline in the EQ-5D-5L index and EQ-VAS through W100 were assessed. Observed changes from baseline were evaluated; in pts who met treatment failure rules before W24 and in pts who discontinued with missing data after W24, changes from baseline were imputed as 0. Results GUS-treated pts achieved greater improvements in pt-reported health status than PBO at both W16 and W24 when evaluated using both the EQ-5D-5L index score and the EQ-VAS. The improvements by GUS in EQ-5D-5L index scores through W24 (0.12 for GUS Q4W/Q8W vs 0.05 for PBO; each nominal p&lt;0.0001) were maintained with continued GUS through 2 years (0.15 for GUS Q4W/Q8W) (Table 1). PBO-treated pts who started GUS at W24 reported comparable improvements in their HRQoL by W52 (0.12), with maintenance though W100 (0.14). Similar results were observed with EQ-VAS (Figure 1). W24 improvements in EQ-VAS scores were greater following GUS treatment (18.2/18.4 GUS Q4W/Q8W) vs PBO (6.8; nominal p&lt;0.0001). EQ-VAS scores continued to improve with GUS through 2 years (25.0/24.6 GUS Q4W/Q8W). Likewise, PBO-treated pts who crossed over to GUS at W24 experienced improvements in HRQoL by W52 (18.8), with maintenance through W100 (21.2). Table 1. LS mean change from baseline through W100 in EQ-5D-5L index GUS 100mg Q4W(W0-100) GUS 100mg Q8W(W0-100) PBO → GUS 100 mg Q4W PBO(W0-24) GUS(W24-100) Week 16 24 100 16 24 100 16 24 100 N 243 244 243 247 246 248 244 244 244 LS mean change (95% CI) 0.10 (0.09,0.12) 0.12 (0.1,0.13) 0.15 (0.13,0.16) 0.11 (0.1,0.13) 0.12 (0.1,0.13) 0.15 (0.13,0.17) 0.06 (0.04,0.07) 0.05 (0.04,0.07) 0.14 (0.12,0.16) Diff vs. PBO 0.04 (0.02,0.06) 0.06 (0.04,0.09) -- 0.05 (0.03,0.07) 0.06 (0.04,0.08) -- -- -- -- Nominal p-value &lt;0.0001 &lt;0.0001 -- &lt;0.0001 &lt;0.0001 -- -- -- -- CI=Confidence interval; Diff=Difference Conclusion In bio-naïve pts with active PsA receiving GUS, earlier improvements (at the first timepoint assessed) in self-reported HRQoL measures were sustained through 2 years. References [1]Mease PJ, et al. Lancet. 2020;395:1126–36. [2]EuroQol Group. 1990;16:199-208. Disclosure of Interests Jeffrey Curtis Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, CorEvitas, Eli Lilly, Janssen, Myriad, Novartis, Pfizer, Sanofi, and UCB, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, CorEvitas, Eli Lilly, Janssen, Myriad, Novartis, Pfizer, Sanofi, and UCB, Iain McInnes Shareholder of: Causeway Therapeutics, and Evelo Compugen, Consultant of: Astra Zeneca, AbbVie, Amgen, Bristol-Myers Squibb, Cabaletta, Compugen, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, Roche, Sanofi, and UCB, Grant/research support from: Astra Zeneca, Amgen, Bristol-Myers Squibb, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB, Proton Rahman Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB, Grant/research support from: Janssen and Novartis, Dafna D Gladman Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Eli Lilly, Janssen, Pfizer, and UCB, Feifei Yang Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Global Services, LLC (a wholly owned subsidiary of Johnson &amp; Johnson), Steve Peterson Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Global Services, LLC (a wholly owned subsidiary of Johnson &amp; Johnson), Alexa Kollmeier Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Development, LLC (a wholly owned subsidiary of Johnson &amp; Johnson), Natalie Shiff Shareholder of: AbbVie, Gilead, and Johnson &amp; Johnson, Employee of: Janssen Scientific Affairs, LLC (a wholly owned subsidiary of Johnson &amp; Johnson), Chenglong Han Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Development, LLC (a wholly owned subsidiary of Johnson &amp; Johnson), May Shawi Shareholder of: Johnson &amp; Johnson, Employee of: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies (a wholly owned subsidiary of Johnson &amp; Johnson), William Tillett Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Eli Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Eli Lilly, Janssen, and UCB, Philip J Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, SUN Pharma, and UCB, Consultant of: AbbVie, Aclaris, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, GSK, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, SUN Pharma, and UCB